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# FDA Accepts Emergent BioSolutions sBLA for BioThrax
- URL: https://www.fdaweb.com/fda-accepts-emergent-biosolutions-sbla-for-biothrax/
- Published: 2016-06-17T12:00:00.000Z
- Updated: 2026-09-14T21:10:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135975

FDA has accepted for review an Emergent BioSolutions supplemental BLA seeking approval to make BioThrax (anthrax vaccine adsorbed) at the company’s large-scale manufacturing facility (building 55). “Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses annually, is in response to the U.S. government’s desire to stockpile 75 million doses of a licensed anthrax vaccine,” the company says. The agency has set a user fee target action date of 8/15.

The sBLA, the company says, is supported by data that demonstrate that BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility. BioThrax is indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease.